Immunic(US:IMUX) Prnewswire·2025-11-13 11:30Core Insights - Immunic, Inc. presented significant data on vidofludimus calcium's therapeutic potential for multiple sclerosis (MS) at the 41st Congress of ECTRIMS, highlighting its ability to improve disability outcomes in progressive MS and its neuroprotective properties [1][2][5] Clinical Development - Phase 2 CALLIPER trial data showed a statistically significant 24-week confirmed disability improvement in progressive MS, with consistent results across various subgroups, supporting the drug's neuroprotective potential [1][2][5] - Long-term data from the phase 2 EMPhASIS trial indicated high rates of patients remaining free from confirmed disability worsening, demonstrating favorable safety and tolerability over treatment durations of up to 5.5 years [1][2][5] - Top-line data from the twin phase 3 ENSURE trials in relapsing MS is expected by the end of 2026, with the potential to address a significant market need in progressive MS [1][2][5] Financial Performance - Research and Development (R&D) expenses for Q3 2025 were $20.0 million, a decrease from $21.4 million in Q3 2024, primarily due to reduced external development costs [4][6] - General and Administrative (G&A) expenses increased to $6.0 million in Q3 2025 from $4.4 million in Q3 2024, driven by higher personnel costs [9] - The net loss for Q3 2025 was approximately $25.6 million, compared to a net loss of $24.4 million in Q3 2024, reflecting an increase in weighted average common shares outstanding [9][10] Intellectual Property - The company received a Notice of Allowance from the U.S. Patent and Trademark Office for a key patent covering dose strengths of vidofludimus calcium for the treatment of progressive MS, potentially extending market exclusivity into 2041 [2][5] Market Opportunity - With only one approved therapy currently available for primary progressive MS, vidofludimus calcium presents a significant opportunity in an underserved multi-billion-dollar market [2][5]